BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM LOCKING SCREW D.4.0 MM-L.20 MM

    MDR report key: 2551376 · Received April 19, 2012

    Report

    Report Number
    9680825-2012-00014
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    March 9, 2012
    Report Date
    April 18, 2012
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THIS SPECIFIC LOT BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2011, WAS COMPRISED OF 117 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER SIMILAR FAILURES HAVE BEEN REPORTED FROM THIS SPECIFIC DEVICE LOT. TECH INVESTIGATION: THE RETURNED DEVICE, RECEIVED ON (B)(4), 2012 IS CURRENTLY UNDER TECHNICAL INVESTIGATION. AS SOON AS THE RESULTS OF THE TECHNICAL INVESTIGATION WILL BE AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL HAS REQUESTED TO THE HOSP INVOLVED PT¿S DETAILS INCLUDED THE CURRENT HEALTH CONDITION AND COPY OF THE PRE AND POST OPERATIVE X-RAYS. UNFORTUNATELY, THIS INFO HAS NOT YET MADE AVAILABLE. ORTHOFIX SRL CONTINUES MONITORING THE DEVICE ON THE MARKET.

    Description of Event or Problem · 1

    THE INFO PROVIDED BY THE TERRITORY MGR STATED: ¿DURING SURGERY, THE HEAD OF THE TITANIUM LOCKING SCREW, CODE 99-T74420, BROKE. THE BREAKAGE OCCURRED BY TIGHTENING THE SCREW NORMALLY. THE SHAFT OF THE SCREW WAS LEFT IN THE NAIL APPLIED IN PT¿S HUMERUS. NO ADVERSE EFFECTS FOR THE PT HAVE BEEN REPORTED.¿ (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM LOCKING SCREW D.4.0 MM-L.20 MM TITANIUM LOCKING SCREW D.4.0 MM-L.20 MM HSB ORTHOFIX SRL 99-T74420 V1221979

    Patients

    Seq Age Sex Outcome Treatment
    1